Trial of New Investigational AIDS Vaccine Begins in New York

NEW YORK -- The Aaron Diamond AIDS Research Center (ADARC), an affiliate of The Rockefeller University, and the International AIDS Vaccine Initiative (IAVI) announced today that they have begun a human trial of a new investigational vaccine to prevent HIV/AIDS. The trial is actively seeking healthy volunteers in New York City and Rochester, N.Y.

The trial is designed to evaluate the safety of a new DNA vaccine called ADVAX. The vaccine is designed to stimulate immune responses to prevent people who are uninfected with HIV/AIDS from contracting the disease, and the trial will gather preliminary data on whether ADVAX stimulates these immune responses.

The vaccine is tailored for the C strain of HIV that accounts for the most HIV infections worldwide and is prevalent in China and other developing countries, where millions of people are being infected with HIV every year. ADARC and IAVI have agreed that if ADVAX proves effective, it will be made available in developing countries at reasonable prices.

"There is an urgent need to slow the spread of HIV in the world, particularly in regions such as Asia that are experiencing rapidly increasing HIV infections," said Dr. David Ho, director of ADARC and Rockefeller University's Irene Diamond Professor. "This trial will help science to gain important information to move us towards the development of an effective vaccine, which could ultimately benefit countless people."

"A preventive vaccine is the world's best hope to stop the spread of the epidemic," said Dr. Seth Berkley, president and CEO of IAVI. "ADVAX is a promising approach that broadens the pipeline of AIDS vaccines in human trials."

The latest figures from UNAIDS are that approximately 14,000 people are becoming infected with HIV each day.

"Rockefeller University and the Aaron Diamond AIDS Center conducted the initial studies on HIV combination therapy in 1995," said Paul Nurse, president of Rockefeller University and Nobel laureate for medicine. "We are hopeful that, in 2003, this vaccine trial will also add significantly to our goal of turning back this terrible epidemic through the development of a vaccine that can help prevent HIV infection in the first place."

"It is imperative that scientists and community members work together to develop a safe and effective AIDS vaccine," said Chris Collins, executive director of AIDS Vaccine Advocacy Coalition (AVAC). "Community engagement in these efforts is essential to achieve progress in the fight against HIV/AIDS."

The ADVAX vaccine uses synthetic DNA based on a part of the genetic material found in HIV. Unlike traditional vaccines that contain a weakened or killed form of a disease-causing agent, DNA vaccines instead contain only portions of the genetic material. This means ADVAX cannot cause HIV infection or AIDS.

The trial will enroll 45 healthy volunteers, both men and women, over the next few months. Study participants must be healthy, HIV-negative and at low risk of HIV infection. Participants will be assigned at random to receive either the investigational vaccine or an inactive solution, known as a placebo. Volunteers will visit the outpatient clinics (in either The Rockefeller University Hospital in New York City or the University of Rochester Medical Center) 12 times over 19 months.

Source: Aaron Diamond AIDS Research Center; International AIDS Vaccine